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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Maverick SARS-CoV-2 Multi-Antigen Serology Panel

Manufactured by Genalyte, United States - www.genalyte.com/ 

Device identification number
721
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antigen
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Semiquantitative
Time
20 minutes
Detection Principle
Phosphor technology
Accuracy
98 %
Clinical Sensitivity
87 %
Clinical Specificity
100 %
Type of antigen
SARS-CoV-2
Notes
Serological panel, Photonic ring resonance

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements